Health Law Vitals - A Healthcare Newsletter from Haynes and Boone, March 2018
by Stacy Brainin, Suzanne Trigg, Taryn McDonald, Neil Issar, Kayla Cristales
Published: March, 2018
Submission: March, 2018
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was reevaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities.The bills reawakened a debate about the pros and cons of POHs. Critics - mainly the nonprofit community and for-profit hospitals - remain concerned that POHs “cherry pick” healthier patients undergoing procedures with higher reimbursement rates. Non-POHs are then left to scavenge on low-reimbursement or non-paying patients, which threatens their existence in an increasingly competitive healthcare environment. Critics also accuse POHs of providing no benefit in terms of cost savings or patient outcomes.
History of Homeopathic Remedies and Regulation in the United States
Homeopathy has been used around the world since the late 1700s. Generally, it is based on two principles: (1) a substance that causes symptoms in a healthy person can be used in a diluted form to treat symptoms and illnesses (referred to as “likecures-like”); and (2) the more diluted a substance, the greater its potency. The first federal food and drug statute, the Food and Drugs Act of 1906, did not reference homeopathy and instead recognized the U.S. Pharmacopeia (USP) and the National Formulary (NF) as the country’s exclusive drug compendia, meaning that only preparations listed in those two publications were defined as “drugs.” Preparations that did not conform to the publications’ standards could be deemed “adulterated,” rendering their manufacture unlawful. At the time, this included preparations listed in the Homeopathic Pharmacopoeia of the United States (HPUS), a recognized compilation of homeopathic medicines published in 1897.
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